External catheters used for male urinary evacuation, e.g in male incontinence devices and the like. typically comprise a sheath applied to the user's penis wherein the sheath has a constricted downstream end portion adapted for fluid-tight connection with a drain tube. The sheath is typically of a thin, elastomeric fluid-impermeable material such as latex rubber or silicone rubber. This sheath is essentially similar to a condom which can be rolled onto the penis.
Problems associated with such prior art external catheters include discomfort caused by prolonged contact of the rubber sheath with the penis, difficulty in maintaining the sheath in a sealably connected arrangement with the penis, and difficulty in unrolling the sheath onto the penis.
U.S. Pat. Nos. 3,863,638 to Rogers, III et al.; 4,187,851 to Hauser and 4,475,909 to Eisenberg describe similar methods for securing the sheath of such an external catheter to the penis in a comfortable manner.
Rogers, III et al. describe an adhesive pad which is wrapped around the penis at least 1.5 times. The pad serves to maintain contact between the sheath and the penis and also protects at least a portion of the penis from extended contact with the sheath.
Hauser has described a tape which is padded and which, by virtue of its lesser width when compared to the above-described Rogers, III et al. pad, is able to accommodate a broader range of sizes. The tape can be wrapped in a partially overlapping fashion to cover the area desired.
Eisenberg has eliminated the bulkiness caused by the overlap of Hauser and Rogers by designing an adhesive cushion which encircles the penis with no overlap necessary.
In all three of the above designs, the rubber sheath can still cause substantial skin irritation to that portion of the penis not protected by the tapes or pads described. Additionally, the outside of the sheath causes irritation to the thigh or crotch area with which it is usually in contact. Even small amounts of urine, in the areas where the sheath touches the skin, greatly augments the skin irritation.
U.S. Pat. No. 3,608,552 to Broerman describes a male urinal device wherein the sheath is fabricated by stretching a tubular woven fabric base over a suitable mold and dipping the same into a rubber compound which is liquid in its uncured state. The resulting sheath has enhanced rigidity due to the fabric base and comprises essentially a rubber impregnated fabric on its inside and the cured rubber on the outside. This less flexible sheath can result in leakage problems as the patient moves around. Additionally, the penis is still contacted to a large extent by the rubber of the sheath and the rubber outside of the sheath can still cause skin irritation to the thigh and/or crotch area.